Device Classification Name |
transcutaneous nerve stimulator for adhd
|
De Novo Number |
DEN180041 |
Device Name |
Monarch eTNS System |
Requester |
NeuroSigma, Inc |
10960 wilshire boulevard |
suite 1910 |
los angeles,
CA
90024
|
|
Contact |
ian a. cook |
|
Regulation Number | 882.5898
|
Classification Product Code |
|
Date Received | 07/30/2018 |
Decision Date | 04/19/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|